VITEK 2 AST-N447 TEST KIT Product reference 424620 recall (Biomerieux Inc)
Medical deviceClass IIOngoing
Summary: Biomerieux Inc is recalling VITEK 2 AST-N447 TEST KIT Product reference 424620. Reason: Potential for false resistant carbapenem and/or cephalosporin results when analyzing samples with kits from affected lot that have pouch foil fractures.
What is being recalled
VITEK 2 AST-N447 TEST KIT Product reference 424620
Why
Potential for false resistant carbapenem and/or cephalosporin results when analyzing samples with kits from affected lot that have pouch foil fractures.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
International distribution to the countries of Belgium and the Netherlands.
How to tell if yours is affected
Lot 0853293604 UDI-DI 03573026634551 Product is not registered in the US. OUS only.
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2715-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | June 4, 2026 |
| Reported | July 15, 2026 |
| Company | Biomerieux Inc |
| Company location | Hazelwood, MO, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 45,900 cards |
More recalls from Biomerieux Inc · all medical device recalls · recalls from June 2026